[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastasis-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastasis-colorectal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100535711","phase-2-study-of-fruquintinib-combined-with-tegafur-gimeracil-oteracil-in-patients-with-metastatic-colorectal-cancer-100535711",false,"NCT06255379","Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer","An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC","Inclusion Criteria:\n\n1. ≥ 18 and ≤ 75 years of age;\n2. Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;\n3. Histologically and\u002For cytologically documented metastatic colorectal adenocarcinoma;\n4. Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;\n5. At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);\n6. ECOG performance status of 0-1;\n7. Life expectancy ≥ 12 weeks;\n8. No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);\n9. Adequate hepatic, renal, heart, and hematologic functions;\n10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;\n3. Previous treatment with Tegafur Gimeracil Oteracil ;\n4. Participated in clinical trials of other drugs within four weeks before enrollment;\n5. Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;\n6. International normalized ratio (INR) \\> 1.5 or partially activated prothrombin time (APTT) \\> 1.5 × ULN;\n7. Clinically significant electrolyte abnormalities;\n8. Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and \u002F or diastolic blood pressure ≥ 90 mmHg;\n9. Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;\n10. Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;\n11. Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;\n12. History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;\n13. Stroke and \u002F or transient cerebral ischemia occurred within 12 months before enrollment;\n14. Cardiovascular diseases with significant clinical significance;\n15. LVEF\\\u003C50%;\n16. Congestive heart failure New York Heart Association (NYHA) grade \\> 2;\n17. Evidence of CNS metastasis;\n18. Previous treatment with VEGFR inhibition;\n19. Ventricular arrhythmias requiring drug treatment;\n20. Proteinuria ≥ 2+ (1.0g\u002F24hr);\n21. Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;\n22. Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;\n23. Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;\n24. By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.","ALL","18 Years","75 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC",[27,28,29],"Metastasis Colorectal Cancer","Colon Cancer","Rectal Cancer",[31,32,33,34],"Colorectal cancer","Fruquintinib","Tegafur Gimeracil Oteracil","mCRC","NOT_YET_RECRUITING","2024-04-26",{"date":38,"type":39},"2024-04-29","ACTUAL",{"date":41,"type":21},"2024-05-06",{"date":43,"type":21},"2027-03-21",{"name":45,"class":46},"Guangzhou University of Traditional Chinese Medicine","OTHER"]